QUESTIONS & ANSWERS
1. Why do people often choose Eastern European countries to apply for GMP as Western European countries?
2. Validity GMP certificate
4. During the 3 years of validity of a GMP certificate, is it necessary to export at least one batch of product to the European market for GMP re-inspection?
3. Who has the authority to issue EU GMP certification?
- GMP certificate is valid for three years from the most recent date of inspection, but the period of validity can be shortened under special circumstances.
- Since a GMP certificate refer to a specific inspection, it can not be renewed or reissued until a new inspection is conducted and completed with adequate follow-up.
- Although the same EU GMP standard. however it seems that inspectors in Eastern European countries are "easy going" than inspectors in Western European countries.
- Eastern European countries are often selected to apply for GMP such as Hungary, Croatia, Malta, Romania.
- When applying for EU GMP and scheduling inspection, the authorities of these countries are not required to submit simultaneously the MA dossier application.
The Drug Administration of the EU countries includes 28 countries: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, The Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden.
Within 3 years of validity of the EU GMP certificate, the manufacturer must produce and export at least 1 batch of products to the EU market to have the right to be re-validated.